Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Odense University Hospital

Status: Unknown

Conditions: Endoscopy, Digestive System; Stomach Neoplasms; Esophageal Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT01185483

ESD-HYBRID-AFDA

Details and patient eligibility

About

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Submucosal tumor (< 4 cm)
• Mucosal tumor (T1) in patients unsuitable for surgery

Exclusion criteria

• Endoscopic ultrasound (EUS) or CT signs of metastasis
• Insufficient access to tumor